Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210132
Company: MAYNE PHARMA
Company: MAYNE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BIJUVA | ESTRADIOL; PROGESTERONE | 1MG;100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
BIJUVA | ESTRADIOL; PROGESTERONE | 0.5MG;100MG | CAPSULE;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/28/2018 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210132Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210132s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210132Orig1s011ltr.pdf | |
12/28/2021 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s006ltr.pdf | |
06/22/2021 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf | |
06/22/2021 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210132s011lbl.pdf | |
12/28/2021 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf | |
06/22/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf | |
06/22/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf | |
10/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf |
BIJUVA
CAPSULE;ORAL; 1MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BIJUVA | ESTRADIOL; PROGESTERONE | 1MG;100MG | CAPSULE;ORAL | Prescription | Yes | AB | 210132 | MAYNE PHARMA |